A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Novartis Pharmaceuticals1 site in 1 country15 target enrollmentSeptember 2004

ConditionsKidney Transplantation

DrugsEnteric-Coated Mycophenolate Sodium (EC-MPS)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Kidney Transplantation
Sponsor: Novartis Pharmaceuticals
Enrollment: 15
Locations: 1
Primary Endpoint: Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

January 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Recipients of a primary renal transplantation
•Recipients of a renal transplantation only

Exclusion Criteria

•Recipients of a multi-organ transplantation
•Unable to take an oral medication
•Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
•Other protocol-defined inclusion / exclusion criteria may apply

Outcomes

Primary Outcomes

Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation

Secondary Outcomes

Within the 6 and 12 months post transplantation
Incidence of acute rejection resistant to steroids
Incidence of graft loss and death
Renal function by creatinine and creatinine clearance (Schwartz formula)
Incidence of premature study drug discontinuation due to safety reason
Pharmacokinetic profile of Myfortic.
Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.